Serration balloon

ABSTRACT

A serration balloon can have a number of different components and can be made in a number of different manners. One or more longitudinally extending members with periodic raised wedges can be attached to a medical balloon. They can be attached with a fiber coating, a polymer coating, or other methods. A polymer matrix can be used to bond the longitudinally extending member to the surface of the balloon. The fiber coating can be, for example, a thread or mesh that secures the longitudinally extending member to the balloon. The medical balloon can be an angioplasty balloon, such as an off-the-shelf angioplasty balloon.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

This application claims priority to U.S. Provisional App. No. 62/074586filed Nov. 3, 2014. All of the above application(s) is/are incorporatedby reference herein in their entirety and are to be considered a part ofthis specification. Any and all applications for which a foreign ordomestic priority claim is identified in the Application Data Sheet asfiled with the present application are hereby incorporated by referenceunder 37 CFR 1.57.

BACKGROUND Field of the Invention

Certain embodiments disclosed herein relate generally to a medicalballoon, for example a medical cutting or serration balloon. Particularembodiments disclose features of a medical balloon such as anangioplasty balloon having adjustable outer dimensions, surfaceprotrusions, and methods of controlled tearing of plaque during anangioplasty procedure.

Description of the Related Art

Atherosclerotic occlusive disease is the primary cause of stroke, heartattack, limb loss, and death in the US and the industrialized world.Atherosclerotic plaque forms a hard layer along the wall of an arteryand is comprised of calcium, cholesterol, compacted thrombus andcellular debris. As the atherosclerotic disease progresses, the bloodsupply intended to pass through a specific blood vessel is diminished oreven prevented by the occlusive process. One of the most widely utilizedmethods of treating clinically significant atherosclerotic plaque isballoon angioplasty.

Balloon angioplasty is a method of opening blocked or narrowed bloodvessels in the body. The balloon angioplasty catheter is placed into theartery from a remote access site that is created either percutaneouslyor through open exposure of the artery. The catheter is typically passedalong the inside of the blood vessel over a wire that guides the way ofthe catheter. A portion of the catheter with a balloon attached isplaced at the location of the atherosclerotic plaque that requirestreatment. The balloon is inflated, generally to a size consistent withthe original diameter of the artery prior to developing occlusivedisease.

When the balloon is inflated, the plaque may be stretched, compressed,fractured, and/or broken, depending on its composition, location, andthe amount of pressure exerted by the balloon. Plaque can beheterogeneous and may be soft in some areas or hard in others causingunpredictable cleavage planes to form under standard balloonangioplasty. Balloon angioplasty can cause plaque disruption andsometimes it causes arterial injury at the angioplasty site. There is acontinuing need to improve the methods and systems for treatingocclusive disease, including balloon angioplasty methods and systems.

SUMMARY OF THE INVENTION

A cutting or serration balloon can have a number of different componentsand can be made in a number of different manners. For example, one ormore longitudinally extending members with periodic raised wedges can beattached to a medical balloon. They can be attached with a fibercoating, a polymer coating, or other methods. The fiber coating can be,for example, a thread or mesh that secures the longitudinally extendingmember to the balloon. In other embodiments, a polymer matrix can beused to bond the longitudinally extending member to the surface of theballoon. In some embodiments, the medical balloon can be an angioplastyballoon. In some embodiments, the medical balloon can be anoff-the-shelf medical balloon, such as an off-the-shelf angioplastyballoon.

A serration balloon can comprise an off-the shelf medical balloon, suchas an angioplasty balloon, with a plurality of cutting blades along asurface of the medical balloon. Each cutting blade of the plurality ofcutting blades can comprise a strip of material with periodic raisedwedges spaced along a length thereof. The plurality of cutting bladescan be secured to balloon surface by a polymer matrix. The polymermatrix can be positioned between the plurality of cutting blades and theballoon surface, while also being around each of the plurality ofcutting blades. The polymer matrix can be applied to the balloon priorto securing the plurality of cutting blades to the balloon and then thesame polymer matrix can be reapplied to secure the plurality of cuttingblades in place.

In some embodiments, each cutting blade of the plurality of cuttingblades is a flat, planar piece of material that has the periodic raisedwedges cut out along a length of the material. The flat, planar piece ofmaterial defining a primary plane, and the periodic raised wedges beingin plane with the primary plane of the flat, planar piece of material.The plurality of cutting blades can be positioned along the surface ofthe medical balloon in the inflated state such that the primary plane isperpendicular to the surface of the medical balloon where it isattached. The flat, planar piece of material can not have a base orflange or other feature that extends outward from the side of the flat,planar piece of material. In addition, the periodic raised wedges can besolid and non-hollow (i.e. non needle-like).

A method of manufacturing a serration balloon can comprise inflating amedical balloon, the medical balloon being on a catheter; dipping themedical balloon in the inflated state in a polymer matrix, such that themedical balloon has first layer of the polymer matrix; attaching aplurality of cutting blades along a surface of the medical balloon inthe inflated state, each cutting blade of the plurality of cuttingblades comprising a strip of material with periodic raised wedges spacedalong a length thereof; and dipping the medical balloon in the inflatedstate with the attached plurality of cutting blades in the polymermatrix to form an over mold, such that at least a portion of eachcutting blade of the plurality of cutting blades is sandwiched betweenthe first layer of the polymer matrix and a second layer of the firstpolymer matrix.

A method of manufacturing a serration balloon can comprise inflating amedical balloon, the medical balloon being on a catheter; attaching aplurality of cutting blades along the surface of the medical balloon inthe inflated state, each cutting blade of the plurality of cuttingblades comprising a strip of material with periodic raised wedges spacedalong a length thereof; and dipping the medical balloon in the inflatedstate with the attached plurality of cutting blades in a polymer matrixto form an over mold securing the plurality of cutting blades to themedical balloon.

A method of manufacturing a serration balloon can comprise inflating amedical balloon, the medical balloon being on a catheter; dipping themedical balloon in the inflated state in a polymer matrix to form afirst layer of polymer matrix on an outer surface of the medicalballoon; attaching a plurality of cutting blades to the first layer ofpolymer matrix along the surface of the medical balloon in the inflatedstate, each cutting blade of the plurality of cutting blades comprisinga strip of material with periodic raised wedges spaced along a lengththereof; and dipping the medical balloon in the inflated state with theattached plurality of cutting blades in the polymer matrix to form anover mold, a second layer of polymer matrix further securing theplurality of cutting blades to the first layer or polymer matrix and themedical balloon.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments are depicted in the accompanying drawings forillustrative purposes, and should in no way be interpreted, as limitingthe scope of the inventions, in which like reference characters denotecorresponding features consistently throughout similar embodiments.

FIG. 1 is a perspective view of a cutting or serration balloon with afiber coating in an inflated state.

FIG. 2 shows a cutting or serration balloon with a fiber coating in adeflated state.

FIG. 3 shows another cutting or serration balloon with fiber coating.

FIG. 4 illustrates a catheter balloon.

FIG. 5 shows an embodiment of a cutting or serration balloon.

FIG. 6 is a cross-sectional detail view of a cutting or serrationballoon.

DETAILED DESCRIPTION

Disclosed herein are various embodiments of systems and methodsdiscussed primarily in the context of treating occlusive disease,including balloon angioplasty methods and systems. At the same time, itwill be understood that the concepts and principles embodied in thevarious embodiments can also be used with other types of medicalballoons, cutting balloons, and other types of medical procedures.

A cutting or serration balloon can have a number of different componentsand can be made in a number of different manners. For example, one ormore longitudinally extending members with periodic raised wedges can beattached to a medical balloon. They can be attached with a fibercoating, a polymer coating, or other methods, various embodiments ofwhich will be discussed below. The fiber coating can be, for example, athread or mesh that secures the longitudinally extending member to theballoon. In other embodiments, a polymer matrix can be used to bond thelongitudinally extending member to the surface of the balloon. In someembodiments, the medical balloon can be an angioplasty balloon. In someembodiments, the medical balloon can be an off-the-shelf medicalballoon, such as an off-the-shelf angioplasty balloon.

FIG. 1 shows a cutting or serration balloon with fiber coating 200including a catheter 40, a balloon 30, at least one longitudinallyextending member 20, and fiber 50. As seen in FIG. 1, in someembodiments, fiber 50 is a thread that is wound about the balloon 30 andthe at least one longitudinally extending member 20. FIG. 2 shows thecutting balloon 200 in a deflated state. As can be seen, the balloon 30can be wrapped around the catheter 40. A sheath 60 can also be used tosecure the balloon in the deflated state prior to expansion.

FIG. 3 shows a similar cutting balloon with fiber coating 300 whereinthe fiber 50 forms a mesh. In some embodiments, a cutting balloon withfiber coating 200, 300 can include at least one radiopaque marker (notpictured). The at least one radiopaque marker is located on the catheter40 to assist with placement and identification of the balloon 30 in thebody.

FIG. 3 provides a view of the balloon 30 and at least one longitudinallyextending member 20 without the fiber 50. FIG. 3 shows a cutting balloonwithout the fiber coating 200 and including a catheter 40, a balloon 30,and at least one longitudinally extending member 20. The balloon 30 canbe attached to the catheter 40 and each of the longitudinally extendingmembers 20 are attached to the surface of the balloon 30.

FIG. 4 shows a catheter balloon 10. The illustrated catheter balloon 10can be an off-the-shelf medical balloon, such as an angioplasty balloon.The catheter balloon 10 can be used to create a serration or cuttingballoon. As shown, the catheter balloon has a catheter shaft 40 with aballoon 30 at the distal end. Radiopaque markers 42 are shown positionedinside the balloon 30. The shaft 40 can be hollow and can be used toinflate the balloon and can also be used with a guidewire. Thus, asshown, the shaft 40 can have two channels, one for inflation and one forpositioning with a guidewire. A hub 44 is shown with two entry pointsfor the shaft 40 and can be a y-hub and strain relief.

In some embodiments the catheter can be a coaxial over-the-wire ballooncatheter with a guidewire size compatibility of 0.018″. A high pressure(non-compliant/semi-compliant) trifold balloon can be made of nylonmaterial with a diameter of 5 mm and a length of 20 mm ±1 mm. Theballoon has a nominal inflation pressure of 10 atm, a rated burstpressure of 22 atm, and an average burst pressure of 22 atm. Thecatheter working length is 110 cm ±2 cm and has a tapered tip length of3 mm ±0.5 mm. Two standard radiopaque makers 42 are made up of 90%platinum and 10% iridium. The radiopaque markers 42 indicate the balloonworking length. The inner shaft has a lubricious HDPE inner layer. Theprofile of the outer shaft is clear and 4.3FR (0.056 in ±0.0008 in; 1.42mm ±0.0200 mm.

The balloon 30 is disposed about the catheter 40 and is capable of beinginflated. In some embodiments the balloon 30 is disposed about thedistal end of the catheter 40 to be used in balloon angioplasty. Inballoon angioplasty, the balloon can be inflated in order tomechanically widen or narrow obstructed arteries from plaque or otherrelated deposits in the lumen of the blood vessel. As will be describedbelow in more detail, structures can be attached to the surface of theballoon 30 that can be used to cut or score the plaque as the balloon 30is expanded. Such an expansion opens up the blood vessel for improvedflow. Subsequent to this procedure, the balloon 30 can be deflated andwithdrawn from the body. In some embodiments, the balloon is a highpressure balloon. In some embodiments, the balloon 30 is made of nylon,has a diameter of 5 mm and can withstand a pressure of up to 22 atm.

Longitudinally extending members 20 can be positioned about the balloon30. Each of the longitudinally extending members 20 include a pluralityof periodic raised wedges 22 that are spaced apart by a plurality ofgrooves 24. The periodic raised wedges can have a height between 100 umto 500 um, more commonly between 150 um and 300 um, and frequentlybetween 200 um and 250 um. The periodic raised wedges 22 extendlongitudinally along the longitudinally extending members 20 each with alength that can be between 100 um to 1 mm, more commonly between 350 umand 750 um, and frequently between 400 um and 550 um. While theplurality of grooves 24 can extend longitudinally along thelongitudinally extending members 20 each with a length that is between 1times to 3 times the length of the periodic raised wedges 22, that canbe between 100 um to 3 mm, more commonly between 350 um and 2 mm, andfrequently between 800 um and 1.2 mm. In the illustrated embodiments,the longitudinally extending members 20 are strips of metal withrectangular shapes cut perpendicular to the length of the strips with alaser, EDM, grinding wheel, or similar to form the periodic raisedwedges 22 and grooves 24. In some embodiments, the longitudinallyextending members 20 can be in the form of strips, wires, ribbons,fibers, splines, etc. The periodic raised wedges 22 and grooves 24 canalso vary in size and shape. In some embodiments, the periodic raisedwedges 22 can have a height of 0.01 inches. In some embodiments, theperiodic raised wedges 22 can be pointed, rounded, trapezoidal or can beshaped protrusions attached to the surface of the longitudinallyextending members 20. The strips of metal can be flat, rounded,trapezoidal, or triangular in cross section.

The longitudinally extending members 20 can be attached to the balloonin a number of different ways. For example the longitudinally extendingmembers 20 can be glued to the balloon. The longitudinally extendingmembers 20 can be attached with a fiber, a polymer matrix, or othermaterial.

In some embodiments, each longitudinally extending member 20 is a flat,planar piece of material that has the periodic raised wedges 22 cut outalong a length of the material. The flat, planar piece of materialdefining a primary plane, and the periodic raised wedges being in planewith the primary plane of the flat, planar piece of material. Thelongitudinally extending members 20 can be positioned along the surfaceof the medical balloon in the inflated state such that the primary planeis perpendicular to the surface of the medical balloon where it isattached. For example, that longitudinally extending members 20 can bepositioned to be aligned with the longitudinal axis of the catheter andthe balloon. The flat, planar piece of material can not have a base orflange or other feature that extends outward from the side of the flat,planar piece of material. In addition, the periodic raised wedges can besolid and non-hollow (i.e. non-needle-like).

As shown in FIGS. 1-3 a fiber 50 can be used to attach thelongitudinally extending members 20 to the balloon. The fiber 50 isdisposed about the surface of the balloon 40 and the longitudinallyextending members 20. The fiber 50 can come in a variety of forms. Inone embodiment, as seen in FIG. 1, the fiber 50 is in the form of athread that is wound about the surface of the balloon 30 and thelongitudinally extending members 20. In some embodiments, the thread canbe constructed of a variety of materials which include metal, plastic,natural fibers, etc. The thread can be of any number of differentconstructions including, single strand, multi-strand, a coating orseries of strands around a core, etc. In another embodiment, as seen inFIG. 3, the fiber 50 is in the form of a mesh that is disposed about theballoon 30 and the longitudinally extending members 20. The mesh can bemade of the same types of materials as the thread. In some embodimentsthe mesh can be constructed of a variety of materials which includemetal, plastic, natural fibers, etc. In some embodiments, the fiber 50can be a variety of thicknesses and shapes and can take on a number ofconfigurations such as woven, knitted, knotted, etc.

The cutting balloon with fiber coating 200 can be created in a number ofways. For example in some embodiments, the balloon 30 is first broughtto an expanded state. This can be done by inflating the balloon. Oncethe balloon 30 is expanded, the longitudinally extending members 20 areplaced about the surface of the expanded balloon and secured to theballoon by the fiber 50. In the embodiment pictured in FIG. 1, the fiber50 is a thread and wound about the surface of the balloon 30 and thegrooves 24 of the longitudinally extending members 20. In anotherexample, in the embodiment pictured in FIG. 2, the fiber 50 is a meshthat is secured to the balloon 30 on the proximal and distal ends of theballoon 30. The intersecting fibers of the mesh engage with the grooves24 of the longitudinally extending members 20. The combined structure ofthe expanded balloon 30, longitudinally extending members 20, and fiber50 is then covered in an adhesive mixture or polymer matrix as describedbelow. The balloon 30 can then be deflated prior to insertion into thepatient. After manufacturing, the cutting balloon with fiber coating 200can be covered with a balloon protector or sheath 60 that can be madeof, for example, PTFE. As well, the cutting balloon with fiber coating200 can be further packaged by placing the cutting balloon into a coiledhoop and then placed into a re-closeable bag in a carton. The sheath 60can helps to prevent the periodic raised wedges 22 of the longitudinallyextending members 20 from unintentional contact with the patient as itis inserted.

A cutting balloon can include longitudinally extending members 20,balloon 30, catheter 40 and fiber 50 discussed above. In someembodiments, the balloon 30 is located on the distal end of the catheter40. In some embodiments, the fiber 50 is only wrapped about the balloon30 and spans from the proximal end of the balloon 30 to the distal endof the balloon 30.

In some embodiments, the cutting balloon has three longitudinallyextending members 20 that are equally spaced radially around the balloon30. The longitudinally extending members 20 can be attached to the flatsurface of the balloon 30. The fiber 50 is a thread that is wrappedabout the longitudinally extending members 20 and secures each of thelongitudinally extending members 20 to the surface of the balloon 30 bysecuring the grooves 24 that are located between each of the periodicraised wedges 22 on the longitudinally extending members 20.

Once the cutting balloon with fiber coating 200 is inserted into thebody of a patient and navigated to the target site, the balloon 30 canbe expanded in a controlled fashion so that the longitudinally extendingmembers 20 can be pushed against the walls of the lumen surface. Theballoon 30 can be controllably inflated to increase its diameter. As theballoon 30 is inflated, the attached longitudinally extending members 20are pushed outwards against the lumen. The periodic raised wedges 22 ofthe longitudinally extending members 20 can engage with the plaque inthe lumen walls when the balloon 30 is expanded.

Other manufacturing methods can also he used. For example, thelongitudinally extending members 20 can be sandwiched between twoballoons. Such devices may or may not also include fibers 50. In anothermethod, the longitudinally extending members 20 can be secured to theballoon during the balloon molding process. Further, the polymermaterial used to form the balloon can also be used to form the fiber 50.The balloon and fiber can be cured together with the longitudinallyextending members 20 installed.

Turning now to FIG. 5, another embodiment of serration or cuttingballoon 100 will be discussed. FIG. 5 provides a view of the balloon 30and at least one longitudinally extending member 20 that has been overmolded. To achieve an over mold one method is to immerse the inflatedballoon 30 into a solution such as a polymer matrix. The polymer matrixcan be at least one of a urethane, nylon, silicon, or alternateelastomeric material designed to offer flexibility while offering goodadhesion, cohesion and biocompatibility properties. These materials canbe hydrophilic, hydrated or non-hydrated, UV curable, and/or dissolvablein organic or inorganic solvents. It will also be understood that thepolymer matrix can comprise one or more different polymer matrixes,where for example the balloon is dipped in a particular order.

The balloon 30 can be dipped and then remain immersed in a solution fora given amount of time to allow a thin layer to deposit itself on theballoon. The balloon 30 with the coating can be allowed to drain and thesolvent to evaporate. Then the balloon can be dipped again multipletimes until an adequate layer is achieved. The longitudinally extendingmembers 20 can then be attached to the balloon, followed by additionaldipping into the polymer matrix. This can secure the longitudinallyextending members 20 to the balloon with layers of the polymer matrixforming a strong bond to the balloon and the longitudinally extendingmembers 20.

In some embodiments to aid the over mold in retention of thelongitudinally extending members 20 to the balloon 30, thelongitudinally extending members 20 can be dipped into the polymermatrix prior to attaching the longitudinally extending members 20 to theballoon. This may be in addition to or instead of bonding thelongitudinally extending members 20 to the coated balloon with anadhesive material. Adhesive bonding to the coated balloon can beachieved with one or more points of attachment or along the entirelength of the longitudinally extending members 20. After thelongitudinally extending members 20 are affixed to the coated balloonsurface a series of additional dips can be performed to achieve anaffective retention layer. Since the longitudinally extending members 20contain a series of recesses 24 between the periodic raised wedges 22 ofmetal, a backbone or strip of material can be identified offering asurface platform that the over mold or polymer coating can flow over andform a blanket or second layer of balloon to retain the longitudinallyextending members 20.

FIG. 6 shows a cross-sectional detail view of a serration balloon. Theballoon 30 is shown with two layers of polymer matrix 70, an adhesivelayer 80 and a longitudinally extending member 20. As illustrated it canbe seen that the longitudinally extending member 20 is sandwichedbetween layers of the polymer matrix 70. The polymer matrix 70 may ormay not cover the wedges 2.

Whether the additive material is fiber, mesh, dip/s, second balloon, orstrip/s of material added to the outside of the balloon, the material onthe outside of the balloon may be completely or selectively doped with adrug or STEM cell matrix through a series of surface ionic bondingmanipulation. One such method of surface ionic bonding manipulation isperformed by exposing the additive material to an environment with aselected ionic charge. Following selected ionic charging of the balloonsurface the balloon can then be exposed to an alternate charge dopantfilled environment to be adhered to the surface by ionic bondingenergies. This process is repeatable until a suitable layer of desireddopant/s is achieved. A photolithographic process or other selectiveprocess such as templated assembly of selective removal may be employed.

The balloon 30 with the over mold can also be doped with a drug or STEMcell matrix through a series of surface ionic bonding manipulation. Onesuch method of surface ionic bonding manipulation is performed byexposing the balloon 30 to an environment with a selected ionic charge.Following selected ionic charging of the balloon surface the balloon canthen be exposed to an alternate charge dopant filled environment to beadhered to the surface by ionic bonding energies. This process isrepeatable until a suitable layer of desired dopant/s is achieved.

A serration balloon can comprise an off-the shelf medical balloon, suchas an angioplasty balloon, with a plurality of cutting blades along asurface of the medical balloon. Each cutting blade of the plurality ofcutting blades can comprise a strip of material with periodic raisedwedges spaced along a length thereof. The plurality of cutting bladescan be secured to balloon surface by a polymer matrix. The polymermatrix can be positioned between the plurality of cutting blades and theballoon surface, while also being around each of the plurality ofcutting blades. The polymer matrix can be applied to the balloon priorto securing the plurality of cutting blades to the balloon and then thesame polymer matrix can be reapplied to secure the plurality of cuttingblades in place.

A method of manufacturing a serration balloon can comprise inflating amedical balloon, the medical balloon being on a catheter; dipping themedical balloon in the inflated state in a polymer matrix, such that themedical balloon has first layer of the polymer matrix; attaching aplurality of cutting blades along a surface of the medical balloon inthe inflated state, each cutting blade of the plurality of cuttingblades comprising a strip of material with periodic raised wedges spacedalong a length thereof; and dipping the medical balloon in the inflatedstate with the attached plurality of cutting blades in the polymermatrix to form an over mold, such that at least a portion of eachcutting blade of the plurality of cutting blades is sandwiched betweenthe first layer of the polymer matrix and a second layer of the firstpolymer matrix.

The method can further comprises applying an adhesive material to abottom surface of each cutting blade of the plurality of cutting bladesprior to attaching the plurality of cutting blades along the surface ofthe medical balloon. The method can further comprise dipping eachcutting blade of the plurality of cutting blades into the polymer matrixprior to dipping the medical balloon with the attached plurality ofcutting blades in the polymer matrix. Applying an adhesive material to abottom surface of each cutting blade of the plurality of cutting bladesprior to attaching the plurality of cutting blades along the surface ofthe medical balloon and after dipping each cutting blade of theplurality of cutting blades into the polymer matrix.

A method of manufacturing a serration balloon can comprise inflating amedical balloon, the medical balloon being on a catheter; attaching aplurality of cutting blades along the surface of the medical balloon inthe inflated state, each cutting blade of the plurality of cuttingblades comprising a strip of material with periodic raised wedges spacedalong a length thereof; and dipping the medical balloon in the inflatedstate with the attached plurality of cutting blades in a polymer matrixto form an over mold securing the plurality of cutting blades to themedical balloon.

In some embodiments, the cutting blades can comprise strips of metalwith a plurality of identical periodic raised wedges spaced along alength thereof, the periodic raised wedges not being hollow. The methodcan further comprise forming each cutting blade of the plurality ofcutting blades from a flat, planar piece of material by cutting out theperiodic raised wedges along a length of the material, the flat, planarpiece of material defining a primary plane, and the periodic raisedwedges being in plane with the primary plane of the flat, planar pieceof material. Attaching the plurality of cutting blades along the surfaceof the medical balloon in the inflated state can further compriseattaching each cutting blade such that the primary plane isperpendicular to the surface of the medical balloon where it isattached. The flat, planar piece of material can not have a base orflange or other feature that extends outward from the side of the flat,planar piece of material.

A serration balloon can comprise an off-the shelf medical balloon, suchas an angioplasty balloon, with a plurality of cutting blades along asurface of the medical balloon. Each cutting blade of the plurality ofcutting blades can comprise a strip of material with periodic raisedwedges spaced along a length thereof. The plurality of cutting bladescan be secured to balloon surface by a polymer matrix. The polymermatrix can be positioned between the plurality of cutting blades and theballoon surface, while also being around each of the plurality ofcutting blades. The polymer matrix can be applied to the balloon priorto securing the plurality of cutting blades to the balloon and then thesame polymer matrix can be reapplied to secure the plurality of cuttingblades in place.

In some embodiments, each cutting blade of the plurality of cuttingblades is a flat, planar piece of material that has the periodic raisedwedges cut out along a length of the material. The flat, planar piece ofmaterial defining a primary plane, and the periodic raised wedges beingin plane with the primary plane of the flat, planar piece of material.The plurality of cutting blades can be positioned along the surface ofthe medical balloon in the inflated state such that the primary plane isperpendicular to the surface of the medical balloon where it isattached. The flat, planar piece of material can not have a base orflange or other feature that extends outward from the side of the flat,planar piece of material. In addition, the periodic raised wedges can besolid and non-hollow (i.e. non-needle-like).

A serration balloon can include an off-the shelf medical balloon; aplurality of cutting blades along a surface of the medical balloon, eachcutting blade of the plurality of cutting blades comprising a strip ofmaterial with periodic raised wedges spaced along a length thereof; anda multi-layer polymer matrix, the plurality of cutting blades secured tothe balloon surface by the multi-layer polymer matrix, the multi-layerpolymer matrix positioned between the plurality of cutting blades andthe balloon surface, while also being around each of the plurality ofcutting blades. The polymer matrix can be applied to the balloon priorto securing the plurality of cutting blades to the balloon and then thesame polymer matrix (or combination of polymer matrixes) can bereapplied to secure the plurality of cutting blades in place.

A benefit of the controlled balloon expansion system is it can allow forcontrol of the angle of energy departed to the surface of the bodylumen. According to some embodiments, this may be achieved throughcontrol of the depth of longitudinally extending members or the diameterat which the constrained balloon makes contact with the lumen wall. Witha controlled depth of the longitudinally extending members, an angulardepression can he generated along the lumen axis of the balloon that canapply a tangential force against the lumen wall at an angle of 45degrees or less perpendicular to the lumen axis. At this angle the lumentissue is susceptible to separating along the mid line of the depressedregion. It can be noted that when attempting to tear a 2-D surface it isobserved that an angle less than 90 degrees exists and offers greatercontrol for predetermining the tear location and reduces the energyrequired to start and facilitate the continuation of a tear in the 2-Dsurface of many materials. When inducing expansion of arteries or otherlumen tissue it is observed that the angle of energy departed at thelumen surface has an expansion effect at a similar angle to that asobserved in the 2-D surface example. It has been observed that anglesequal to or less than 45 degrees appear to have beneficial tearingeffects on plaque in a blood vessel, although other predetermined anglesmay be used when tissue expansion is not the only desired effect.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. In addition, while a number of variations of the invention havebeen shown and described in detail, other modifications, which arewithin the scope of this invention, will be readily apparent to those ofskill in the art based upon this disclosure. It is also contemplatedthat various combinations or sub-combinations of the specific featuresand aspects of the embodiments may be made and still fall within thescope of the invention. Accordingly, it should be understood thatvarious features and aspects of the disclosed embodiments can becombined with or substituted for one another in order to form varyingmodes of the disclosed invention. Thus, it is intended that the scope ofthe present invention herein disclosed should not be limited by theparticular disclosed embodiments described above, but should bedetermined only by a fair reading of the claims that follow.

Similarly, this method of disclosure, is not to he interpreted asreflecting an intention that any claim require more features than areexpressly recited in that claim. Rather, as the following claimsreflect, inventive aspects lie in a combination of fewer than allfeatures of any single foregoing disclosed embodiment. Thus, the claimsfollowing the Detailed Description are hereby expressly incorporatedinto this Detailed Description, with each claim standing on its own as aseparate embodiment.

1. A method of manufacturing a serration balloon, comprising: inflatinga medical balloon, the medical balloon being on a catheter; dipping themedical balloon in the inflated state in a polymer matrix, such that themedical balloon has first layer of the polymer matrix; attaching aplurality of cutting blades along a surface of the medical balloon inthe inflated state, each cutting blade of the plurality of cuttingblades comprising a strip of material with periodic raised wedges spacedalong a length thereof; and dipping the medical balloon in the inflatedstate with the attached plurality of cutting blades in the polymermatrix to form an over mold, such that at least a portion of eachcutting blade of the plurality of cutting blades is sandwiched betweenthe first layer of the polymer matrix and a second layer of the firstpolymer matrix.
 2. The method of claim 1, wherein dipping the medicalballoon comprises dipping an off-the-shelf angioplasty balloon in thepolymer matrix.
 3. The method of claim 1, wherein the polymer matrixcomprises at least one of urethane, nylon, and silicon.
 4. The method ofclaim 1, further comprising draining excess of the polymer matrix fromthe medical balloon.
 5. The method of claim 4, further comprisingallowing a solvent from the polymer matrix to evaporate.
 6. The methodof claim 1, further comprising applying an adhesive material to a bottomsurface of each cutting blade of the plurality of cutting blades priorto attaching the plurality of cutting blades along the surface of themedical balloon.
 7. The method of claim 1, further comprising dippingeach cutting blade of the plurality of cutting blades into the polymermatrix prior to dipping the medical balloon with the attached pluralityof cutting blades in the polymer matrix.
 8. The method of claim 7,further comprising applying an adhesive material to a bottom surface ofeach cutting blade of the plurality of cutting blades prior to attachingthe plurality of cutting blades along the surface of the medical balloonand after dipping each cutting blade of the plurality of cutting bladesinto the polymer matrix.
 9. The method of claim 1, further comprisingdoping the medical balloon with the attached plurality of cutting bladesand the over mold with a drug or STEM cell matrix.
 10. The method ofclaim 9, wherein doping further comprises exposing the balloon to anenvironment with a selected ionic charge and then exposing the balloonto an alternate charge dopant filled environment.
 11. The method ofclaim 1, wherein the cutting blades comprise strips of metal with aplurality of identical periodic raised wedges spaced along a lengththereof, the periodic raised wedges not being hollow.
 12. The method ofclaim 1, wherein the periodic raised wedges each have a height between100 um to 500 um, 150 um and 300 um, and 200 um and 250 um.
 13. Themethod of claim 12, wherein the periodic raised wedges each have alength between 100 um to 1 mm, 350 um and 750 um, and 400 um and 550 um.14. The method of claim 13, wherein the periodic raised wedges are basedapart by a plurality of grooves, each groove being 1 times to 3 timesthe length of at least one of the periodic raised wedges.
 15. The methodof claim 13, wherein the periodic raised wedges are based apart by aplurality of grooves, each groove having a length of between 100 um to 3mm, 350 um and 2 mm, and 800 um and 1.2 mm.
 16. The method of claim 1,further comprising forming each cutting blade of the plurality ofcutting blades from a flat, planar piece of material by cutting out theperiodic raised wedges along a length of the material, the flat, planarpiece of material defining a primary plane, and the periodic raisedwedges being in plane with the primary plane of the flat, planar pieceof material.
 17. The method of claim 1, wherein attaching the pluralityof cutting blades along the surface of the medical balloon in theinflated state further comprises attaching each cutting blade such thatthe primary plane is perpendicular to the surface of the medical balloonwhere it is attached.
 18. The method of claim 17, wherein there theflat, planar piece of material does not have a base or flange or otherfeature that extends outward from the side of the flat, planar piece ofmaterial.
 19. The method of claim 1, wherein the polymer matrixcomprises a first polymer matrix and a second polymer matrix and thesteps of dipping the medical balloon into the polymer matrix comprisesdipping the medical balloon into the first polymer matrix followed bydipping the balloon into the second polymer matrix.
 20. A method ofmanufacturing a serration balloon, comprising: inflating a medicalballoon, the medical balloon being on a catheter; dipping the medicalballoon in the inflated state in a polymer matrix to form a first layerof polymer matrix on an outer surface of the medical balloon; attachinga plurality of cutting blades to the first layer of polymer matrix alongthe surface of the medical balloon in the inflated state, each cuttingblade of the plurality of cutting blades comprising a strip of materialwith periodic raised wedges spaced along a length thereof; and dippingthe medical balloon in the inflated state with the attached plurality ofcutting blades in the polymer matrix to form an over mold, a secondlayer of polymer matrix further securing the plurality of cutting bladesto the first layer or polymer matrix and the medical balloon. 21-25.(canceled)